Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures

Radiographic and Clinical Outcomes Following Non-operative Versus Operative Treatment of AO Type A3 Fractures: A Prospective, Randomized Clinical Trial With an Observational Component

The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Fractures
• Intervention / Treatment: Procedure: Surgery + Bracing vs. Bracing Alone; Other: Patient's Choice

Detailed Description

Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine [vertebra] breaks due to immediate and severe compression).

The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Unviersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-65 years
2. Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
3. Neurologically intact
4. TLICS score of 4
5. Women of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

1. Severe poly-trauma (Injury Severity Score >15 and/or intubation required for > 24 hours)
2. Sepsis and/or organ failure
3. Prior instrumented arthrodesis of the thoracolumbar spine
4. Severe co-morbidities (e.g., heart, respiratory, or renal disease)
5. Recent history (<3 years) of concomitant spinal tumor or infection
6. Greater than single level fracture involvement (other than transverse process fractures)
7. AO Type A3 fracture with associated load sharing score ≥7
8. ≥ 30 degrees regional kyphosis on standing
9. History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis)
10. History of osteoporosis
11. Subjects who are pregnant or plan to become pregnant in the next 24 months. Patients will be advised on the use of contraceptives during this time. Methods include abstinence or two acceptable forms including condoms with spermicide, birth control pills, injections, or an IUD.
12. Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate)
13. Severe morbid obesity (BMI > 40)
14. History of metal sensitivity/foreign body sensitivity
15. History of prior laminectomy at the fracture site
16. Associated scoliotic (> 10°) or pre-existing thoracolumbar kyphotic deformity
17. History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
18. Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery + Bracing vs. Bracing Alone; Randomize between 2 treatments: Treatment 1: Surgery + Bracing Treatment 2: Bracing alone	Procedure: Surgery + Bracing vs. Bracing Alone; Surgery + Bracing vs. Bracing Alone
Other: Patient's choice; Patient will decide which group is best for him/her. The patient will be followed at the same points as Group 1.	Other: Patient's Choice; Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare radiologic outcomes using regional kyphosis and Evaluate clinical outcomes using questionnaires	Primary Outcome is to compare radiologic and clinical outcomes. These will be measured by regional kyphosis, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients; and Oswestry Disability Index, at 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare radiologic outcomes using regional kyphosis	Secondary outcome is to compare radiologic outcomes, as measured by regional kyphosis, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients	5 and 10 years
Evaluate clinical outcomes using questionnaires	Secondary outcome is to evaluate clinical outcomes, as measured by the Oswestry Disability Index, at 5 and 10 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.	5 and 10 years
Compare global sagittal balance at 3 different time points	Secondary Outcome is to compare global sagittal balance at 2, 5, and 10 years.	2,5, and 10 years
Collect data on patient in both groups for 10 years	Secondary Outcome is to record frequency and time to secondary surgical intervention among patients in the bracing group.	10 years
Compare Return to work rates over a two year peiord	Secondary Outcome is to Compare return-to-work rates at 3 months, 1 year, and 2 years following either non-operative or operative management of thoracolumbar AO type A3.1, A3.2, A3.3 fractures in neurologically-intact patients.	3 month, 1 year, and 2 years
Compare Health Care Cost between both groups over 10 years	Secondary Outcome is to compare health care cost and utilization through extended follow-up period.	10 years

Collaborators and Investigators

• Sponsor: H Francis Farhadi
• Investigators: Principal Investigator: Francis Frahadi, MD, PhD, Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Groups:; Group 1 (2 Treatment Arms (Randomized between 2 treatments)); Treatment 1: Surgery + Bracing; Treatment 2: Bracing Alone; Group 2; The patient will decide which group is best for themselves.
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: 2014H0100